DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)

Intervention: Aclidinium Bromide / Formoterol Fumarate (Drug); Salmeterol / Fluticasone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Estrella Garcia, Ph.D., Study Director, Affiliation: Almirall Global Clinical Operations

Summary

The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)

Clinical Details

Official title: A Randomised, Double-blind, Double-dummy, Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Twice-daily Aclidinium Bromide/Formoterol Fumarate Compared With Twice-daily Salmeterol/Fluticasone Propionate for 24 Weeks Treatment in Symptomatic Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Peak forced expiratory volume in one second (FEV1) at week 24

Secondary outcome: Transition Dyspnoea Index (TDI) focal score at week 24

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult male or non-pregnant, non-lactating female aged ≥40.

- Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years

- Patients with a clinical diagnosis of COPD according to GOLD guidelines 2013, with a

post-bronchodilator FEV1 <80%, and FEV1/FVC < 70% at Screening Visits

- Symptomatic patients with a COPD assessment test (CAT) ≥10 at Screening and

Randomisation Visits

- Patient must be able to perform repeatable pulmonary function testing for FEV1

according to ATS/ERS 2005 criteria at Screening Visits

- Patients eligible and able to participate in the trial and who consent to do so in

writing after the purpose and nature of the investigation have been explained Exclusion Criteria:

- History or current diagnosis of asthma

- Development of a respiratory tract infection or COPD exacerbation within 6 weeks (or

3 months if hospitalisation was required) before the Screening Visit or during the run-in period

- Clinically significant respiratory conditions

- Type I or uncontrolled Type II diabetes, uncontrolled hypo- or hyperthyroidism,

hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension

- Patients who, in the investigator's opinion, may need to start a pulmonary

rehabilitation programme during the study and/or patients who started/finished it within 3 months prior to Screening Visit

- Use of long-term oxygen therapy (≥15 hours/day)

- Patients treated on daily basis with triple therapy (LABA+LAMA+ICS) within 4 weeks

prior to the Screening Visit

- Patient who does not maintain regular day/night, waking/sleeping cycles including

night shift workers

- Clinically significant cardiovascular conditions

- Patient with clinically relevant abnormalities in the results of the clinical

laboratory tests, ECG parameters or in the physical examination at the Screening Visit

- Patient with a history of hypersensitivity reaction to inhaled anticholinergics,

sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm)

- Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute

urinary retention, or patients with symptomatic non-stable prostatic hypertrophy

- Patient with known non-controlled history of infection with human immunodeficiency

virus (HIV) and/or active hepatitis

- History of malignancy of any organ system (including lung cancer), treated or

untreated, within the past 5 years other than basal or squamous cell skin cancer

- Patient with any other serious or uncontrolled physical or mental dysfunction

- Patient with a history (within 2 years prior to Screening Visit) of drug and/or

alcohol abuse that may prevent study compliance based on investigator judgment

- Patient unlikely to be cooperative or that can't comply with the study procedures

- Patient treated with any investigational drug within 30 days (or 6 half-lives,

whichever is longer) prior to Screening Visit

- Patient who intend to use any concomitant medication not permitted by this protocol

or who have not undergone the required stabilization periods for prohibited medication

- Any other conditions that, in the investigator's opinion, might indicate the patient

to be unsuitable for the study

Locations and Contacts

Almirall Investigational Site, Feldbach 8330, Austria

Almirall Investigational Site, Feldkirch 6800, Austria

Almirall Investigational Site, Grieskirchen A-4710, Austria

Almirall Investigational Site, Linz 4020, Austria

Almirall Investigational Site, Salzburg 5020, Austria

Almirall Investigational Site, Dimitrovgrad 6400, Bulgaria

Almirall Investigational Site, Gabrovo 5300, Bulgaria

Almirall Investigational Site, Kozlodui 3320, Bulgaria

Almirall Investigational Site, Petrich 2850, Bulgaria

Almirall Investigational Site, Plovdiv 4000, Bulgaria

Almirall Investigational Site, Razgrad 7200, Bulgaria

Almirall Investigational Site, Stara Zagora 6003, Bulgaria

Almirall Investigational Site, Vidin 3700, Bulgaria

Almirall Investigational Site, Karlovy Vary 360 09, Czech Republic

Almirall Investigational Site, Kralupy nad Vltavou 278 01, Czech Republic

Almirall Investigational Site, Liberec 460 63, Czech Republic

Almirall Investigational Site, Ostrava - Hrabuvka 700 30, Czech Republic

Almirall Investigational Site, Rokycany 337 01, Czech Republic

Almirall Investigational Site, Strakonice 386 01, Czech Republic

Almirall Investigational Site, Nîmes 30900, France

Almirall Investigational Site, Perpignan 66025, France

Almirall Investigational Site, Vieux Conde 59690, France

Almirall Investigational Site, Berlin 10117, Germany

Almirall Investigational Site, Berlin 10629, Germany

Almirall Investigational Site, Berlin 10717, Germany

Almirall Investigational Site, Berlin 10969, Germany

Almirall Investigational Site, Berlin 12043, Germany

Almirall Investigational Site, Berlin 13125, Germany

Almirall Investigational Site, Berlin 13581, Germany

Almirall Investigational Site, Berlin 14059, Germany

Almirall Investigational Site, Bochum 44789, Germany

Almirall Investigational Site, Bonn 53123, Germany

Almirall Investigational Site, Cologne 51069, Germany

Almirall Investigational Site, Cottbus 03050, Germany

Almirall Investigational Site, Dortmund 44263, Germany

Almirall Investigational Site, Dresden 01307, Germany

Almirall Investigational Site, Frankfurt 60389, Germany

Almirall Investigational Site, Frankfurt 60596, Germany

Almirall Investigational Site, Gauting 82131, Germany

Almirall Investigational Site, Großhansdorf 22927, Germany

Almirall Investigational Site, Hamburg 20253, Germany

Almirall Investigational Site, Hamburg 20354, Germany

Almirall Investigational Site, Hamburg 22143, Germany

Almirall Investigational Site, Hannover 30159, Germany

Almirall Investigational Site, Jena 07740, Germany

Almirall Investigational Site, Leipzig 4357, Germany

Almirall Investigational Site, Marburg 35037, Germany

Almirall Investigational Site, Munich 80539, Germany

Almirall Investigational Site, Rüdersdorf 15562, Germany

Almirall Investigational Site, Schwabach 91126, Germany

Almirall Investigational Site, Wiesbaden 65187, Germany

Almirall Investigational Site, Wiesloch 69168, Germany

Almirall Investigational Site, Witten 58452, Germany

Almirall Investigational Site, Balassagyarmat 2660, Hungary

Almirall Investigational Site, Budapest 1191, Hungary

Almirall Investigational Site, Budapest 1204, Hungary

Almirall Investigational Site, Debrecen H-4032, Hungary

Almirall Investigational Site, Komárom 2900, Hungary

Almirall Investigational Site, Nyíregyháza 4400, Hungary

Almirall Investigational Site, Pécs H-7635, Hungary

Almirall Investigational Site, Szazhalombatta H-2400, Hungary

Almirall Investigational Site, Szigetszentmiklós H-2310, Hungary

Almirall Investigational Site, Vásárosnamény 4800, Hungary

Almirall Investigational Site, Pisa 56124, Italy

Almirall Investigational Site, Pordenone 33170, Italy

Almirall Investigational Site, Trieste 34149, Italy

Almirall Investigational Site, Kaunas LT-50009, Lithuania

Almirall Investigational Site, Klaipeda LT-92231, Lithuania

Almirall Investigational Site, Klaipeda LT-92288, Lithuania

Almirall Investigational Site, Vilnius LT-01117, Lithuania

Almirall Investigational Site, Almere 1311 RL, Netherlands

Almirall Investigational Site, Beek 6191 JW, Netherlands

Almirall Investigational Site, Eindhoven 5623 EJ, Netherlands

Almirall Investigational Site, Hoofddorp 2134, Netherlands

Almirall Investigational Site, Leeuwarden 8934 AD, Netherlands

Almirall Investigational Site, Rotterdam 3045 PM, Netherlands

Almirall Investigational Site, Bialystok 15-010, Poland

Almirall Investigational Site, Bialystok 15-044, Poland

Almirall Investigational Site, Bialystok 15-270, Poland

Almirall Investigational Site, Gdansk 80-847, Poland

Almirall Investigational Site, Katowice 40-752, Poland

Almirall Investigational Site, Krakow 31-455, Poland

Almirall Investigational Site, Lodz 90-242, Poland

Almirall Investigational Site, Ostrowiec Swietokrzyski 27-400, Poland

Almirall Investigational Site, Pila 64-920, Poland

Almirall Investigational Site, Poznan 60-214, Poland

Almirall Investigational Site, Proszowice 32-100, Poland

Almirall Investigational Site, Sopot 81-741, Poland

Almirall Investigational Site, Szczecin 71-124, Poland

Almirall Investigational Site, Tarnow 33-100, Poland

Almirall Investigational Site, Tczew 83-110, Poland

Almirall Investigational Site, Warsaw 01-138, Poland

Almirall Investigational Site, Wilkowice-Bystra 43-365, Poland

Almirall Investigational Site, Belville 7530, South Africa

Almirall Investigational Site, Cape Town 7700, South Africa

Almirall Investigational Site, Gauteng 158, South Africa

Almirall Investigational Site, Gauteng 1724, South Africa

Almirall Investigational Site, Middelburg 1050, South Africa

Almirall Investigational Site, Pretoria 0184, South Africa

Almirall Investigational Site, Somerset West 7130, South Africa

Almirall Investigational Site, Alicante 03114, Spain

Almirall Investigational Site, Barcelona 08003, Spain

Almirall Investigational Site, Barcelona 08025, Spain

Almirall Investigational Site, Barcelona 08907, Spain

Almirall Investigational Site, Elda 03600, Spain

Almirall Investigational Site, Laredo 39770, Spain

Almirall Investigational Site, Madrid 28007, Spain

Almirall Investigational Site, Palma de Mallorca 07010, Spain

Almirall Investigational Site, Sant Boi de Llobregat 08830, Spain

Almirall Investigational Site, Santander 38008, Spain

Almirall Investigational Site, Seville 41071, Spain

Almirall Investigational Site, Birmingham B15 2SQ, United Kingdom

Almirall Investigational Site, Chorley PR7 7NA, United Kingdom

Almirall Investigational Site, Glasgow G20 0SP, United Kingdom

Almirall Investigational Site, Liverpool L22 0LG, United Kingdom

Almirall Investigational Site, Manchester M15 6SX, United Kingdom

Almirall Investigational Site, Middlesex HA6 2RN, United Kingdom

Almirall Investigational Site, Reading RG2 0TG, United Kingdom

Almirall Investigational Site, Sidcup DA14 6LT, United Kingdom

Almirall Investigational Site, Edmonton, Alberta AB T6G 2B7, Canada

Almirall Investigational Site, Vancouver, British Columbia BC V5Z 1M9, Canada

Almirall Investigational Site, Vancouver, British Columbia BC V7M 2H9, Canada

Almirall Investigational Site, Moncton, New Brunswick NB E1C 5K4, Canada

Almirall Investigational Site, Toronto, Ontario ON M6H 3M2, Canada

Almirall Investigational Site, Saint Romuald, Quebec QC G6W 5M6, Canada

Almirall Investigational Site, Trois-Rivières, Quebec QC G8T 7A1, Canada

Additional Information

Starting date: September 2013
Last updated: August 4, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017